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A First-In-Human, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(T)Ide Therapy and Virologically Suppressed

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Trial Profile

A First-In-Human, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(T)Ide Therapy and Virologically Suppressed

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Nov 2019

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At a glance

  • Drugs JNJ-64300535 (Primary) ; Nucleoside reverse transcriptase inhibitors
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Sponsors Janssen Sciences Ireland UC

    • Most Recent Events

    • 26 Nov 2019 Planned End Date changed from 29 Jan 2021 to 1 Mar 2021.
    • 26 Nov 2019 Planned primary completion date changed from 29 Jan 2021 to 1 Mar 2021.
    • 30 Sep 2019 Planned End Date changed from 20 Nov 2020 to 29 Jan 2021.
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